An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Launched by BRISTOL-MYERS SQUIBB · Dec 15, 2015
Trial Information
Current as of July 21, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called Nivolumab, which is a type of immunotherapy, to see how well it works compared to a placebo (a dummy treatment) in patients who have recently had surgery to remove invasive bladder or upper urinary tract cancer. The main goal is to find out if Nivolumab can help prevent the cancer from coming back after surgery. This trial is currently active but not recruiting new participants.
To be eligible for this study, participants must have had invasive urothelial cancer that is at high risk of recurring and must have undergone major surgery to remove the cancer within the last 120 days. They should also be free of any visible disease based on recent imaging tests. Patients who have not received certain types of chemotherapy before surgery may qualify, while those with recent cancer treatments or certain medical conditions, like active autoimmune diseases, cannot participate. If chosen, participants will receive either Nivolumab or a placebo and will be monitored for effectiveness and safety throughout the study. For more details about participating in this trial, interested individuals can visit the provided website.
Gender
ALL
Eligibility criteria
- • For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Inclusion Criteria:
- • Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
- • Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
- • Must have disease free status as determined by imaging within 4 weeks of dosing
- • Tumor tissue must be provided for biomarker analysis
- • Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
- Exclusion Criteria:
- • Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
- • Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
- • Subjects with active, known or suspected autoimmune disease
- • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
- • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
- • Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
New York, New York, United States
Maywood, Illinois, United States
Mineola, New York, United States
Liverpool, New South Wales, Australia
Miami Beach, Florida, United States
Madrid, , Spain
St. Leonards, New South Wales, Australia
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Frankston, Victoria, Australia
New Orleans, Louisiana, United States
Albany, New York, United States
Tampa, Florida, United States
Portland, Oregon, United States
Norfolk, Virginia, United States
Taichung, , Taiwan
Taipei, , Taiwan
San Francisco, California, United States
Wilton, Cork, Ireland
Lakewood, Colorado, United States
Jerusalem, , Israel
Hasselt, , Belgium
Edmonton, Alberta, Canada
Marseille Cedex 9, , France
Nijmegen, , Netherlands
Elizabeth Vale, South Australia, Australia
Waratah, New South Wales, Australia
Manchester, Greater Manchester, United Kingdom
Sevilla, , Spain
Mexico, Distrito Federal, Mexico
Regensburg, , Germany
Sutton, Surrey, United Kingdom
Porto Alegre, Rio Grande Do Sul, Brazil
Copenhagen, , Denmark
Zerifin, , Israel
Lund, , Sweden
Df, Distrito Federal, Mexico
Basel, , Switzerland
Clermont Ferrand, , France
Guadalajara, Jalisco, Mexico
Las Vegas, Nevada, United States
Nanjing, Jiangsu, China
Xi'an, Shan3xi, China
Chengdu, Sichuan, China
Moscow, , Russian Federation
Villejuif, , France
Aalborg, , Denmark
Amsterdam, , Netherlands
Sacramento, California, United States
Paris, , France
Beijing, Beijing, China
Hangzhou, Zhejiang, China
Mexico City, Distrito Federal, Mexico
Wroclaw, , Poland
Aarhus N, , Denmark
Muenster, , Germany
Fuzhou, Fujian, China
Kaohsiung, , Taiwan
Tucson, Arizona, United States
Shanghai, Shanghai, China
Nanchang, Jiangxi, China
Timisoara, Timis, , Romania
Liege, , Belgium
Nanning, Guangxi, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Maastrict, , Netherlands
Chapel Hill, North Carolina, United States
Stuttgart, , Germany
Roma, , Italy
Jena, , Germany
Sapporo Shi, Hokkaido, Japan
Shinjuku Ku, Tokyo, Japan
Linz, , Austria
Edinburgh, Midlothian, United Kingdom
Nuernberg, , Germany
Omaha, Nebraska, United States
Nagasaki Shi, Nagasaki, Japan
London, , United Kingdom
Pisa, , Italy
Vienna, , Austria
New York, New York, United States
Essen, , Germany
Berazategui, Buenos Aires, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Milano, , Italy
Akita Shi, Akita, Japan
Fukuoka Shi, Fukuoka, Japan
Medellin, , Colombia
Niigata Shi, Niigata, Japan
Dublin, , Ireland
Rio De Janeiro, , Brazil
Bunkyo Ku, Tokyo, Japan
Montreal, Quebec, Canada
Anchorage, Alaska, United States
Capital Federal, Buenos Aires, Argentina
Seoul, , Korea, Republic Of
Fort Wayne, Indiana, United States
Salzburg, , Austria
Pittsburgh, Pennsylvania, United States
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Santiago, Metropolitana, Chile
Zerifin, , Israel
Chiba Shi, Chiba, Japan
Tsukuba Shi, Ibaraki, Japan
Madrid, , Spain
Milano, , Italy
Chattanooga, Tennessee, United States
Arezzo, , Italy
Viedma, Rio Negro, Argentina
Bogota, , Colombia
Bergamo, , Italy
Lima, , Peru
Lodz, , Poland
Saint Petersburg, , Russian Federation
Craiova, , Romania
Floridablanca, , Colombia
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Siena, , Italy
Munich, , Germany
Anchorage, Alaska, United States
Clovis, California, United States
Gainesville, Florida, United States
Grand Rapids, Michigan, United States
Burnsville, Minnesota, United States
Buffalo, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Tigard, Oregon, United States
Allentown, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Ciudad Autónoma De Buenosaires, Buenos Aires, Argentina
Perth, Western Australia, Australia
Wien, , Austria
Ijui, Rio Grande Do Sul, Brazil
Barretos, Sao Paulo, Brazil
Cerqueira Cesar, Sao Paulo, Brazil
São Paulo, , Brazil
Sherbrooke, Quebec, Canada
Montreal, , Canada
Vina Del Mar, Valparaiso, Chile
Temuco, , Chile
Chongqing, Chongqing, China
Guangzhou, Guangdong, China
Yantai, Shandong, China
Shanghai, Shanghai, China
Wenzhou, Zhejiang, China
La Roche Sur Yon, , France
Strasbourg, , France
Suresnes, , France
Chemnitz, , Germany
Greifswald, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Marburg, , Germany
Athens, , Greece
Thessaloniki, , Greece
Haifa, , Israel
Ramat Gan, , Israel
Reggio Emilia, , Italy
Roma, , Italy
Hirosaki, Aomori, Japan
Sapporo, Hokkaido, Japan
Okayama City, Okayama, Japan
Osakasayama, Osaka, Japan
Hamamatasu, Shizuoka, Japan
Osaka, , Japan
Mexico, Distrito Federal, Mexico
Monterrey, Nuevo Leon, Mexico
Gdansk, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucuresti, , Romania
Floresti, , Romania
Badalona Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Santander, , Spain
Zuerich, , Switzerland
Sheffield, Yorkshire, United Kingdom
Tampa, Florida, United States
Rochester, Minnesota, United States
Xi'an, , China
Niigata Shi, Niigata, Japan
Tucson, Arizona, United States
Sacramento, California, United States
San Francisco, California, United States
Lakewood, Colorado, United States
Miami Beach, Florida, United States
Maywood, Illinois, United States
Fort Wayne, Indiana, United States
New Orleans, Louisiana, United States
Burnsville, Minnesota, United States
Omaha, Nebraska, United States
Albany, New York, United States
Mineola, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Portland, Oregon, United States
Portland, Oregon, United States
Tigard, Oregon, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Chattanooga, Tennessee, United States
Norfolk, Virginia, United States
Berazategui, Buenos Aires, Argentina
Capital Federal, Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Ciudad Autónoma De Buenosaires, Buenos Aires, Argentina
Viedma, Rio Negro, Argentina
St. Leonards, New South Wales, Australia
Waratah, New South Wales, Australia
Elizabeth Vale, South Australia, Australia
Frankston, Victoria, Australia
Perth, Western Australia, Australia
Linz, , Austria
Salzburg, , Austria
Vienna, , Austria
Wien, , Austria
Hasselt, , Belgium
Liege, , Belgium
Ijui, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Barretos, Sao Paulo, Brazil
Cerqueira Cesar, Sao Paulo, Brazil
Rio De Janeiro, , Brazil
Edmonton, Alberta, Canada
Montreal, Quebec, Canada
Montreal, , Canada
Santiago, Metropolitana, Chile
Vina Del Mar, Valparaiso, Chile
Temuco, , Chile
Beijing, Beijing, China
Beijing, Beijing, China
Beijing, Beijing, China
Chongqing, Chongqing, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Yantai, Shandong, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Bogota, , Colombia
Floridablanca, , Colombia
Medellin, , Colombia
Aalborg, , Denmark
Aarhus N, , Denmark
Copenhagen, , Denmark
Clermont Ferrand, , France
La Roche Sur Yon, , France
Marseille Cedex 9, , France
Paris, , France
Strasbourg, , France
Suresnes, , France
Chemnitz, , Germany
Essen, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Jena, , Germany
Marburg, , Germany
Muenster, , Germany
Munich, , Germany
Nuernberg, , Germany
Regensburg, , Germany
Stuttgart, , Germany
Athens, , Greece
Thessaloniki, , Greece
Wilton, Cork, Ireland
Dublin, , Ireland
Haifa, , Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Arezzo, , Italy
Bergamo, , Italy
Pisa, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Siena, , Italy
Hirosaki, Aomori, Japan
Fukuoka Shi, Fukuoka, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Tsukuba Shi, Ibaraki, Japan
Nagasaki Shi, Nagasaki, Japan
Okayama City, Okayama, Japan
Osakasayama, Osaka, Japan
Hamamatasu, Shizuoka, Japan
Bunkyo Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Chiba, , Japan
Osaka, , Japan
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Df, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Amsterdam, , Netherlands
Maastrict, , Netherlands
Nijmegen, , Netherlands
Lima, , Peru
Gdansk, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucuresti, , Romania
Craiova, , Romania
Floresti, , Romania
Timisoara, Timis, , Romania
Moscow, , Russian Federation
Saint Petersburg, , Russian Federation
Badalona Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Santander, , Spain
Sevilla, , Spain
Lund, , Sweden
Basel, , Switzerland
Kaohsiung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Sutton, Surrey, United Kingdom
Sheffield, Yorkshire, United Kingdom
London, , United Kingdom
London, , United Kingdom
Las Vegas, Nevada, United States
San Miguel De Tucuman, Tucuman, Argentina
Liverpool, New South Wales, Australia
Nanjing, Jiangsu, China
Wenzhou, Zhejiang, China
Villejuif, , France
Greifswald, , Germany
Roma, , Italy
Akita Shi, Akita, Japan
Osaka, , Japan
Mexico City, Distrito Federal, Mexico
Lodz, , Poland
Wroclaw, , Poland
Zuerich, , Switzerland
Manchester, Greater Manchester, United Kingdom
Edinburgh, Midlothian, United Kingdom
Nijmegen, , Netherlands
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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